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Osteonecrosis of the Jaw (ONJ)
June 14, 2006
/ Reviewed and approved by the Science
and Research Committee of the NOF Board
of Trustees March 3, 2007
What is it?
Recently reports have
described a dental condition, ONJ, in
which bone in the lower jaw or less
commonly the upper jaw becomes exposed,
typically after a dental extraction or
some other trauma to the jaw, and the
wound that occurs fails to heal in the
usual time frame. Infection in the area
can occur and the area may be painful.
This can become a chronic problem in
many of those who develop it. With
careful dental management, use of
antibiotics and daily rinsing of the
mouth with antibiotic solutions some
patients with the condition do
experience healing over time.
Current information suggests that this
condition appears to occur infrequently
in patients with cancer and rarely in
patients with benign conditions such as
osteoporosis or Paget’s disease of bone
who are being treated with
bisphosphonate medications.
Of
the cases reported to date, nearly 95%
were cancer patients receiving an
intravenous bisphosphonate, pamidronate
(Aredia®) or zoledronate (Zometa®),
typically given every three to four
weeks. Although quite unusual, patients
being treated with the bisphosphonate
pills alendronate (Fosamax®) or
risedronate (Actonel®) for osteoporosis
prevention or treatment have also been
reported to have developed ONJ. Fosamax®
and Actonel® have been available in the
U.S. since 1995 and 1998, respectively,
and have been used safely by many
millions of patients.
In
2005, the U.S. Food and Drug
Administration (FDA) decided that a
statement about ONJ would be required in
the safety information provided in the
package inserts of all bisphosphonate
products so that doctors and patients
would have this information.
What are points to
consider?
Whenever a medication is
prescribed, it is important for the
patient to understand both the benefits
and the potential risks or side effects
associated with that medication.
Fosamax® and Actonel®
were approved by the FDA for use in the
prevention and treatment of osteoporosis
after extensive clinical studies found
them to be generally well tolerated and
effective in reducing bone loss to
prevent osteoporosis and in reducing the
likelihood of fractures in patients with
osteoporosis.
Based on information
available to date, the incidence of ONJ
appears to be rare in people taking oral
bisphosphonates. It is important
however, that patients taking
bisphosphonates continue to get regular
dental check-ups and to let their
dentist know about all the medications
they take.
There are reports that some dentists are
advising patients to stop the use of
bisphosphonates for a period of time
(e.g. a month or two) before and after a
tooth extraction or implant surgery, but
there is no clear evidence, at this
time, as to whether this is
necessary.
Summary
Based on the currently
available information, NOF believes that
in the vast majority of patients who are
receiving them the benefits of oral bisphosphonate medications outweigh the
potential risk of ONJ. Patients for whom
bisphosphonates are appropriate would be
at higher risk of fractures without
treatment, and fractures are the source
of significant pain and disability that
impact on function and quality of life.
If a patient receiving
bisphosphonates has planned dental
surgery that involves the bone, a drug
holiday beginning shortly before the
procedure and lasting until there is
local healing could be considered,
although there is as yet no clinical
evidence that this will affect the
incidence or severity of ONJ.
NOF
encourages all osteoporosis patients
taking oral bisphosphonates to maintain
good oral hygiene and get regular dental
visits. Patients are encouraged to
discuss their individual situation with
their doctor or other health care
professional and inform their dentists
that they are taking bisphosphonates. As
clinical information is still incomplete
and the causes not fully understood,
research into ONJ continues. As new
information becomes available, NOF will
be providing updates.
Reference:
Woo SB, Hellstein JW,
Kalmar JR. Systematic review:
bisphosphonates and osteonecrosis of the
jaws. Annals of Internal Medicine.
2006 May 16;144(10):753-61.
Bilezikian, JP. Osteonecrosis of the
jaw: Do bisphosphonates pose a risk?
New England Journal of Medicine. 2006
November 30: 355(22): 2278-2281.
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